KEY-Vaxx is a B-cell peptide cancer vaccine which aims to induce the body to produce polyclonal antibodies that block PD-1 signalling, and potentially produce an anticancer effect similar to Keytruda, Opdivo and the other immune checkpoint inhibitor monoclonal antibodies that are transforming the treatment of a range of cancers.

KEY-Vaxx has shown potential in preclinical studies, outperforming an industry-standard antibody in a mouse model of HER2+ colorectal cancer.

New provisional patent

The protection of Imugene’s global position in PD-1 B-cell cancer vaccines has been strengthened with the filing of a new provisional patent in Australia titled “A vaccine composition and uses thereof”.

READ: Imugene signs exclusive, world-widelicence for cancer vaccine

Imugene managing director Leslie Chong said: “Maintaining and strengthening our already strong international intellectual property position is a key area of focus in maintaining the competitive advantage of KEY-Vaxx and any future improvements, vaccine formulations and clinical uses.

“We are extremely pleased with the progress made from our expert scientific team.”

]]>Mon, 24 Sep 2018 08:07:00 +1000https://www.proactiveinvestors.com.au/companies/news/205478/imugene-begins-manufacture-of-its-innovative-cancer-vaccine-for-trials-205478.htmlhttps://www.proactiveinvestors.com.au/companies/news/198408/imugene-signs-exclusive-world-wide-licence-for-cancer-vaccine-198408.html
Imugene Ltd (ASX:IMU) has expanded its cancer portfolio via a transformational opportunity, and institutional and sophisticated investors have shown their support through a capital raising.

Imugene has now signed an exclusive, world-wide licence to the entire body of cancer vaccine work and intellectual property developed by Professor Pravin T. P. Kaumaya of The Ohio State University Wexner Medical Center and The Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute and The Mayo Clinic.

Professor Kaumaya has developed multiple B-cell cancer vaccines and is a recognised leader in cancer vaccine research with emphasis on peptide cancer vaccines.

There is a growing body of evidence that B-cell peptide vaccines may have a safety and specificity advantage over other immunotherapy approaches.

In particular with PD-1 checkpoint inhibitors, where Ohio State University Comprehensive Cancer Centre’s pre-clinical work for a Phase I PD-1 clinical trial is well advanced.

Funding support

Australian and international institutional and sophisticated investors have committed to raise around $12 million in a placement at 2.7 cents.

Imugene last traded at 3 cents.

There is also a 1 for 3 option attached exercisable at 4 cents on or before 30 November 2021.

Imugene will also open a 1 for 9.5 non-renounceable rights issue on the same terms as the placement, raising up to another $8.1 million.

]]>Thu, 07 Jun 2018 11:29:00 +1000https://www.proactiveinvestors.com.au/companies/news/198408/imugene-signs-exclusive-world-wide-licence-for-cancer-vaccine-198408.htmlhttps://www.proactiveinvestors.com.au/companies/news/198223/imugene-pounces-on-material-acquisition-198223.html
Imugene Ltd (ASX:IMU) has been a strong performer on the ASX, last trading at 3 cents, or more than double its value in January 2018.

The company recently appointed Ms Leslie Chong as managing director. As CEO, Ms Chong achieved various important milestones in both the clinical and corporate fronts.

The next steps for Imugene will be interesting, with the company this morning entering a trading halt pending details of a material acquisition, and subsequent capital raising.

Currently, Imugene's lead product is HER-Vaxx, a B Cell peptide vaccine for the treatment of gastric cancer.

The halt will remain in place until the opening of trade on Thursday 7 June 2018, or earlier if an announcement is made to the market.

Importantly, clinicians have reported no safety, toxicity or tolerability issues with HER-Vaxx during the first cohort dosing of patients.

Dose escalation recommended

The cohort review committee for the study has reviewed the results and has recommended dose escalation.

The clinicians at eight sites across Hong Kong, Taiwan and Thailand will determine if the administration of HER-Vaxx in combination with chemotherapy will prolong survival, delay tumour progression, or reduce the tumour burden in patients with metastatic gastric cancer.

Multi-billion dollar market

HER-Vaxx works by targeting the same receptor as Herceptin and Perjeta, two leading antibody drugs marketed by Roche, with annual sales of US$8.2 billion.

Unlike Herceptin and Perjeta, which are “injected synthetic antibody” products, HER-Vaxx activates the patient’s own immune system to produce a continuous supply of cancer targeting antibodies and induce a response against the tumours.

The early clinical data for HER-Vaxx is encouraging, indicating immune activation in vaccinated patients in a manner that is consistent with the vaccine’s postulated mechanism of action.

HER-Vaxx is a next generation HER2 cancer therapy using B cell peptides, which harness the body’s ability to develop antibodies against the disease.

HER-Vaxx works by targeting the same receptor as Herceptin and Perjeta, two leading antibody drugs marketed by Roche, with annual sales of US$8.2 billion.

To progress the next steps, Imugene is heading to market with a capital raising, and the ASX has granted the company a trading halt to prepare.

The halt will remain in place until the opening of trade on Thursday 23rd November 2017, or earlier if an announcement is made to the market.

]]>Tue, 21 Nov 2017 09:56:00 +1100https://www.proactiveinvestors.com.au/companies/news/187538/imugene-targets-cash-injection-for-immuno-oncology-clinical-testing-187538.htmlhttps://www.proactiveinvestors.com.au/companies/news/181254/imugene-granted-canadian-patent-for-proprietary-cancer-vaccine-181254.html
Imugene (ASX:IMU) has achieved a major milestone by securing a patent for its proprietary cancer vaccine, HER-Vaxx, from the Canadian Patent Office.

The company’s shares were last trading 13% higher intra-day, at A$0.017.

HER-Vaxx is a next generation cancer immunotherapy using B cell peptides, which harness the body’s ability to develop antibodies against the disease.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

HER-Vaxx works by targeting the same receptor (and additional receptors) as Herceptin and Perjeta, two of the leading antibody drugs on market, with annual sales of US$8.2 billion.

Current immunotherapies are predicted to generate sales of US$36 billion by 2025 but costs remain prohibitive for patients.

The mechanism of action for HER-Vaxx may help generate improved efficacy over existing treatments and at a lower cost.

Gastric cancer is a leading cause of cancer death worldwide, representing 10.1% of male cases, with the incidence of gastric cancer substantially higher in Asia.

Imugene had raised circa A$3 million as part of an option plan which expired on 31 March 2017, at a price of A$0.015 per share.

]]>Fri, 21 Jul 2017 13:00:00 +1000https://www.proactiveinvestors.com.au/companies/news/181254/imugene-granted-canadian-patent-for-proprietary-cancer-vaccine-181254.htmlhttps://www.proactiveinvestors.com.au/companies/news/176058/imugene-raises-3m-from-option-plan-to-advance-immunotherapy-studies-176058.html
Imugene (ASX:IMU) has raised circa $3 million as part of an option plan which expired on 31 March 2017, at a price of $0.015 per share.

The new capital places Imugene in a solid position to continue the development of its clinical candidate, HER-Vaxx.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene’s three prominent existing shareholders, Private Portfolio Managers, Platinum Asset Management and Celtic Capital, have increased their investment in Imugene via their roles as underwriters to the plan.

In January 2016, Imugene announced a new partnership with the Medical University of Vienna to discover and develop mimotope-based immunotherapies against validated and new oncology targets.

This partnership has the potential to create B Cell peptide vaccines that would replace or augment conventional monoclonal antibodies.

Importantly, Imugene filed four new patent applications with IP Australia in December 2016 related to mimotope B-cell vaccine compositions.

The company’s share price increased circa 78% during the past six months, last trading at $0.016.

]]>Thu, 06 Apr 2017 14:00:00 +1000https://www.proactiveinvestors.com.au/companies/news/176058/imugene-raises-3m-from-option-plan-to-advance-immunotherapy-studies-176058.htmlhttps://www.proactiveinvestors.com.au/companies/news/169291/imugene-ltd-appoints-leslie-chong-to-chief-executive-officer-169291.html
Chong joined IMU in September 2015 from the pharmaceutical giant, Genentech, in San Francisco where she had a distinguished career across many aspects of drug development.

Imugene is a clinical stage immuno-oncology company, with its lead product being HER-Vaxx, a B Cell peptide vaccine for the treatment of gastric cancer.

The company is also developing mimotope-based immunotherapies against validated and new oncology targets.

]]>Tue, 22 Nov 2016 08:30:00 +1100https://www.proactiveinvestors.com.au/companies/news/169291/imugene-ltd-appoints-leslie-chong-to-chief-executive-officer-169291.htmlhttps://www.proactiveinvestors.com.au/companies/news/167599/imugene-gets-ready-to-raise-167599.html
The halt will remain in place until the opening of trade on Friday 21st October 2016, or earlier if an announcement is made to the market.
]]>Wed, 19 Oct 2016 08:00:00 +1100https://www.proactiveinvestors.com.au/companies/news/167599/imugene-gets-ready-to-raise-167599.htmlhttps://www.proactiveinvestors.com.au/companies/news/165297/imugene-ltd-gets-site-approval-for-gastric-cancer-study-in-thailand-70586.html
Imugene Ltd (ASX:IMU) has received approval from the Faculty of Medicine, Chiang Mai University of Thailand to start site activation process for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

The approval in Thailand follows approvals from Taipei Veterans General Hospital in Taiwan and the University of Hong Kong.

Thailand, Taiwan and Hong Kong and are three of the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Gastric cancer represents an area of high unmet medical need, particularly in Asian countries.

Imugene had $1.6 million in cash as at 30 June 2016.

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>Mon, 22 Aug 2016 13:30:00 +1000https://www.proactiveinvestors.com.au/companies/news/165297/imugene-ltd-gets-site-approval-for-gastric-cancer-study-in-thailand-70586.htmlhttps://www.proactiveinvestors.com.au/companies/news/165296/imugene-ltd-to-start-gastric-cancer-treatment-studies-in-taiwan-70375.html
Imugene Ltd (ASX:IMU) has received approval from the Institutional Review Board of the Taipei Veterans General Hospital in Taiwan for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy in gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Rather than attacking the cancer directly, as chemo does, immunotherapy tries to rally the patient’s own immune system to fight the disease.

The approval in Taiwan follows the University of Hong Kong Institutional Review Board Approval in July.

Hong Kong and Taiwan are two of the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Gastric cancer represents an area of high unmet medical need, particularly in Asia.

Imugene held $1.6 million in cash as at 30 June 2016.

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>Thu, 11 Aug 2016 12:30:00 +1000https://www.proactiveinvestors.com.au/companies/news/165296/imugene-ltd-to-start-gastric-cancer-treatment-studies-in-taiwan-70375.htmlhttps://www.proactiveinvestors.com.au/companies/news/156526/imugene-ltd-gains-approval-for-gastric-cancer-study-in-hong-kong-69717.html
Imugene Ltd (ASX:IMU) has received approval from the University of Hong Kong Institutional Review Board for the Phase 1b/2 study of its HER-Vaxx immuno-oncology therapy for gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

The approval from the Ethics Committee positions Imugene to enrol patients for the eight study sites participating in the initial Phase 1b portion of the upcoming Phase 1b/2 study.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

For Hong Kong there were around 1,100 new gastric cancer cases last year, representing a market for any product that is commercialised from the studies.

Imugene held $2.4 million in cash as at 31 March 2016.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

This filing represents the first submission to various regulators across Asia to initiate clinical testing of Imugene’s HER-Vaxx therapy, given the high unmet need in this area for patients who have HER-2 positive gastric cancer.

HER-Vaxx is a cancer immunotherapy designed to treat HER-2 positive gastric cancer, a cancer with increased levels of a growth-promoting protein called the HER-2 receptor.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

In conjunction with Novotech, Imugene’s contract research organisation for the study, the company has filed to initiate the study with the Department of Health of Hong Kong.

The proposed HER-Vaxx Phase 1b/2 study will be conducted in two parts.

The initial Phase 1b will enrol up to 18 patients to be treated with HER-Vaxx in combination with chemotherapy to interrogate three dose levels.

This first stage is to obtain safety, immunogenicity (a measure of how many of the HER-2 antibodies are produced), evaluate the booster schedule and determine the optimal dose to take into the Phase 2 study.

The larger, open label Phase 2 study will enrol around 68 patients randomised into two arms of either HER-Vaxx plus standard-of-care or standard-of-care alone.

Imugene has identified eight study sites in Asia to participate in the Phase 1b part of the study. Regulatory filings in other jurisdictions will be done in the next two months.

The principal investigator for Imugene’s Hong Kong site will be Dr Thomas Yau, one of Hong Kong’s leading medical oncologists, whose main research priority is gastrointestinal oncology.

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents.

]]>Thu, 21 Apr 2016 16:00:00 +1000https://www.proactiveinvestors.com.au/companies/news/156525/imugene-initiates-pan-asia-trial-of-gastric-cancer-treatment-therapy-68218.htmlhttps://www.proactiveinvestors.com.au/companies/news/156524/imugene-rings-in-changes-as-gastric-cancer-trial-preparation-picks-up-pace--66430.html
Imugene (ASX:IMU) has added Dr. Anton Uvarov to its Board as a non executive director as the immuno-oncology company picks up the pace of work for its gastric cancer study in 2016.

Dr Uvarov worked for two years in the U.S. healthcare research team at Citigroup Global Markets covering small and mid-cap biotechnology companies and holds a PhD degree in Biochemistry and Medical Genetics.

Stuart Roberts was appointed Head of Corporate Development this week. Previously he worked at Prima BioMed (ASX:PRR).

Imugene is a clinical stage immuno-oncology company with a lead product, HER-Vaxx a cancer immunotherapy designed to treat tumours that over-express the HER-2/neu receptor, such as gastric, breast, ovarian, lung and pancreatic cancers.

Immuno-oncology is a relatively new but highly promising field that uses the method of activating a patient's immune system against tumour growth.

Imugene's unique immunotherapy has been shown in pre-clinical work and in one Phase 1 study to stimulate a potent polyclonal antibody response to HER-2/neu, a known and validated cancer target.

HER-Vaxx’s successful Phase 1 study was in patients with breast cancer and the next stage of development will be a Phase 1b/2 study in patients with gastric cancer.

Novotech was recently appointed as the lead contract researcher for the upcoming Phase 1b/2 trial of HER-Vaxx in gastric cancer.

The trial design was largely completed with a focus on Asia. Start up activity for the HER-Vaxx Phase 1b/2 study in gastric cancer is underway and clinical commencement is expected in the first half of 2016.

Under Novotech, Imugene’s investigators will recruit patients with HER-2 positive gastric cancer at a number of leading cancer centres in Asia.

The study will be conducted in two parts. The initial Phase 1b will be an open-label dose escalation study designed to evaluate the safety as well as the pharmacokinetics of HER-Vaxx. This will also determine optimal dosage.

A larger Phase 2 study will be a randomised controlled study of HER-Vaxx plus standard of care against standard of care alone.

Proactive Investors is a global leader reporting financial news, media, research and hosts events for listed emerging growth companies and investors across four continents. ]]>Tue, 05 Jan 2016 11:42:00 +1100https://www.proactiveinvestors.com.au/companies/news/156524/imugene-rings-in-changes-as-gastric-cancer-trial-preparation-picks-up-pace--66430.htmlhttps://www.proactiveinvestors.com.au/companies/news/156523/imugene-cashes-up-ahead-of-hotly-anticipated-cancer-treatment-trials-65323.html
Imugene Limited (ASX:IMU) has further underscored investor confidence in its HER-Vaxx product with about A$756,000 in new government funding as trials for the cancer therapy approach.

The tax refund comes as part of the Australian government’s research and development incentive program, which is aimed at converting innovative research into tangible, market-ready outcomes.

These funds complement Imugene’s $3 million capital raising announced in September and will contribute to the progression of HER-Vaxx, which is due to enter additional human Phase Ib/II gastric cancer clinical trials in 2016.

Imugene chief operating officer Leslie Chong commented:

“This is valuable non-dilutive capital for Imugene. If we succeed in commercialising HER-Vaxx, it will mean a potential Australian blockbuster drug and a better treatment for people who suffer HER2-positive gastric, breast and other cancers.”

Trials of Imugene HER-Vaxx therapy for gastric cancer are expected to demonstrate the medical and commercial viability of the company’s strategy as investors contemplate a multi-decade rollout of patenting and royalties related to a strong intellectual property portfolio.

Imugene IP is exclusive until 2030 and granted in all major jurisdictions. The company, however, is now aiming for an extension of these rights until 2036.

The macro context for this marketing scheme is underpinned by the prevalence and high death rate of gastric cancer, particularly in Japan, Korea and China.

Hot field

The use of immunotherapy to develop vaccines against gastric and breast cancers is considered the hottest area of oncology today thanks to the breakthrough approval last year of the first cancer cell-killing drug for blockading immune checkpoints.

Immune checkpoints are molecules within the immune system which have emerged as increasingly researched targets for treating cancer.

HER-Vaxx trials will explore Imugene’s vaccine on breast cancer by targeting HER-2 receptors on cancer cells. This is a clinically and commercially validated cancer target. The killing of HER-2 receptors results in the host cancer cells stopping growth and dying.

The trial work could improve Imugene’s chances of acquiring orphan drug designation from the U.S. Food and Drug Administration as well as steering development of follow-up clinical candidates using HER-Vaxx technology.

Sharpening profile

In addition to the $3 million share placement last month, the latest R&D refund and the imminent HER-Vaxx trialling, Imugene has bolstered its investment case with the recent appointment of Chong in the role of chief operating officer.

An immune-oncology specialist, Chong served previously as senior clinical program lead at Genetech Inc in the U.S., which is widely regarded as one of the world’s most successful biotech companies with a significant oncology franchise including the best-selling breast cancer drug, Herceptin.

Her deep immuno-oncology experience and industry networks are expected to be invaluable as HER-Vaxx development milestones come into focus.

Analysis

The latest investment has continued to demonstrate the attractiveness of Imugene’s product pipeline, which includes a trial-ready drug targeting the same receptor as the A$6.4 billion breast cancer drug, Herceptin.

This investor enthusiasm also indicates that the upcoming gastric cancer human clinical trials for HER-Vaxx represent a significant share price catalyst next year for this lightly valued $16 million-capped stock.

Imugene's validated HER-2 target and a world-class drug development team in Dr Axel Hoos and Professor Ursula Weidermann provide investors with a credentialed pure-play listed immuno-oncology stock – once the preserve of “big pharma”.

Beyond its HER-Vaxx product holdings, Imugene also owns a drug delivery platform, Linguet, which uses its proprietary technology to improve the efficacy and safety of a diverse number of existing prescription and over-the-counter medicines.

Further product diversification can be found in Imugene’s development of a vitamin D supplement tablet, which melts in the mouth, better known as a “meltlet”. The technology is available for outlicensing to interested parties.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China. ]]>Wed, 28 Oct 2015 14:53:00 +1100https://www.proactiveinvestors.com.au/companies/news/156523/imugene-cashes-up-ahead-of-hotly-anticipated-cancer-treatment-trials-65323.htmlhttps://www.proactiveinvestors.com.au/companies/news/156521/imugene-raises-3m-to-start-gastric-cancer-clinical-trial-64415.html
Imugene (ASX:IMU) has received firm commitments to raise $3 million through a placement of shares priced at $0.0075 each to sophisticated investors.

This includes one free attaching option exercisable at $0.015 and expiring on 31st March 2017 for every two shares subscribed.

The company also plans to issue 2 bonus options for every 15 shares held in the company to shareholders. These have the same terms as the placement options.

The capital raising includes a subscription by non-executive director Otto Buttula for shares amounting to $225,000 and non-executive director Charles Walker for $11,250 worth of shares.

Proceeds will be used to initiate the company’s Phase 1b/2 clinical trial for its HER-Vaxx gastric cancer treatment and additional preclinical work on HER-Vaxx drug combinations.

The company has already appointed global contract research organisation (CRO) Simbec-Orion to conduct the trial and is targeting late this year or early 2016 to commence the Phase 1b trial.

Shareholder approval will be sought at company’s upcoming annual general meeting for the share placement.

Paul Hopper, executive chairman, commented:

“We are delighted to welcome new and existing shareholders to Imugene in this placement. The funds raised from this placement, subject to shareholder approval, in addition to our existing cash position, places us in a strong position to move ahead with our program.

“With our newly appointed COO, Ms. Leslie Chong, commencing her role shortly and the start of clinical trials, we look forward to an exciting time ahead for Imugene.”

Recent Activity

Imugene is in the later stages of planning to conduct a new preclinical study of HER-Vaxx in an additional disease model of gastric cancer.

This could improve the company’s case to achieve orphan drug designation from the United States Food and Drug Administration as well as steering development of follow up clinical candidates using the HER-Vaxx technology.

Chief Scientific Officer Professor Ursula Wiedermann is also conducting additional work at the Medical University of Vienna on the final chosen formulation of HER-Vaxx.

This work is looking to further establish additional evidence of the enhanced efficacy from the new formulation of HER-Vaxx.

HER-Vaxx

HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.

HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.

HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.

Analysis

The $3 million to be raised will allow Imugene to start the HER-Vaxx gastric cancer human clinical trial, which is a key inflection point.

Pre-clinical data had previously showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Imugene had $1.96 million in cash as at 30th June 2015.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

]]>Tue, 08 Sep 2015 12:17:00 +1000https://www.proactiveinvestors.com.au/companies/news/156521/imugene-raises-3m-to-start-gastric-cancer-clinical-trial-64415.htmlhttps://www.proactiveinvestors.com.au/companies/news/156520/imugene-limited-on-road-to-raising-64387.html
Clinical stage immuno-oncology company Imugene Limited (ASX:IMU) has been granted a trading halt by the ASX, with its shares placed in pre-open.

Imugene is currently preparing to release capital raising details.

The company is developing HER-2+ gastric and breast cancer immunotherapies.

The halt will remain in place until the opening of trade on Wednesday 9th September 2015, or earlier if an announcement is made to the market.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

She was most recently a senior clinical program leader at San Francisco-based Genentech, Inc, a global leader in immuno-oncology and developer of Herceptin before it was acquired by Roche in 2009 for US$46.8 billion.

Paul Hopper, executive chairman, commented:

“We are delighted that someone of Leslie’s calibre, deep immuno-oncology experience, industry networks, and from one of the world’s most successful and prestigious drug developers, has agreed to join our team.

“IMU is at an important stage of its clinical development and Leslie’s deep, hands-on clinical trial experience across many studies will be invaluable to us.”

Separately, managing director Charles Walker will step down from his position and continue as a non-executive director of the company.

The Phase 1b/2 clinical study is on track to begin in the second half of 2015. Simbec-Orion will plan and manage the clinical trials with its initial task being to identify optimal international clinical trial sites.

It will also identify investigators experienced in immuno-oncology to participate in the clinical investigation of Imugene’s proprietary immunotherapy HER-Vaxx.

In previous empirical work on breast cancer, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Imugene had $1.96 million in cash as at 30th June 2015.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

The Phase 1b/2 clinical study is on track to begin in the second half of 2015.

Simbec-Orion will plan and manage the clinical trials with its initial task being to identify optimal international clinical trial sites.

It will also identify investigators experienced in immuno-oncology to participate in the clinical investigation of Imugene’s proprietary immunotherapy HER-Vaxx.

In previous empirical work on breast cancer, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Roche’s Herceptin drug, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin though clinical trials are required to confirm this.

Charles Walker, managing director, said:

“This is another milestone passed as the selection of specialist CRO Orion will greatly assist the company conduct a thorough and well prepared immuno-oncology clinical trial.

“Our trial is designed to be statistically robust and also yield early significant data. The trial has been designed to appeal to potential partners and help steer the Phase 3 clinical trial design.

“We look forward to working with our new partner and reporting on the inevitable progress.”

Ronald Openshaw, Simbec-Orion chief executive officer, added:

“We are pleased to prevail in Imugene’s stringent selection process and look forward to driving this important clinical trial.

“We will ensure a combination of rigour and efficiency and are adamant about achieving on timelines and quality of data that should satisfy the US FDA.”

HER-Vaxx

HER-Vaxx is a proprietary HER-2 positive cancer immunotherapy that stimulates a polyclonal antibody response to HER-2/neu.

HER-2/neu is a known and validated receptor over-expressed on various tumours including gastric, breast, ovarian, lung and pancreatic cancers.

HER-Vaxx has successfully completed a Phase 1 study in patients with breast cancer and is now progressing to a Phase 1b/2 study in patients with gastric cancer.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.

Such data may help potential partners in early assessments of the drug and its effect on the immune system, which is a key indicator of improvement in patient survival.

This study will be a key inflection point underpinned by many years of research.

In April, the company developed a new formulation of Her-Vaxx that demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.

Manufacturing has also been simplified with increased reliability and lower cost.

Imugene has also been able to file a new patent that could extend coverage to 2036, which would allow the company another six years on the market at peak sales.

Analysis

The appointment of global CRO Simbec-Orion to fast track plans and logistics for the upcoming HER-Vaxx gastric cancer human clinical trial is a key milestone for Imugene.

The upcoming Phase 1b/2 clinical study in the second half of 2015 is expected to be closely watched given the encouraging pre-clinical data.

This further aligns his interests and remuneration to the achievement of operational milestones, share price appreciation and improved shareholder value.

Dr Hoos is a highly qualified and internationally respected medical research professional who has played a key role in the development of Imugene's HER-2+ gastric and breast cancer therapies and his ongoing involvement and incentivisation is critical for Imugene as it focusses on delivering key milestones.

The issue of options is subject to shareholder approval and the following terms and conditions:

- 2.5 million options exercisable at $0.0125 per option and vest upon recruitment of first patient for Phase 1b trial;- 2.5 million options are exercisable at $0.0175 per option and vest on recruitment of first patient for Phase 2 trial; - Options expire 4 years from the date of issue; and- Any options not vested will lapse if Dr. Hoos ceases to be a director of the company.

Recent Activity

In May, the company released research that demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.

In empirical work, pre-clinical data showed that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China. ]]>Mon, 29 Jun 2015 17:00:00 +1000https://www.proactiveinvestors.com.au/companies/news/156517/imugene-issuing-5-million-options-to-non-executive-director-dr-axel-hoos-63187.htmlhttps://www.proactiveinvestors.com.au/companies/news/156516/imugene-limited-appoints-dr-ursula-wiedermann-as-chief-scientific-officer-62767.html
Imugene Limited (ASX:IMU) has appointed Medical University of Vienna Professor of Vaccinology Dr Ursula Wiedermann as its chief scientific officer.

Notably, she worked as the principal investigator for the preclinical development of the company’s HER-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer alongside Professor Christophe Zielinski.

Together they performed the Phase I Clinical trial of HER-Vaxx in metastatic breast cancer patients.

Wiedermann has a distinguished scientific career with a particular interest in immunology and vaccines with over 110 publications in peer reviewed scientific journals to her credit.

She currently serves on the company’s scientific advisory board.

“This is a real coup for Imugene and we are delighted to have a scientist of such international renown as Prof Dr Wiedermann formalise her position in the Company as CSO,” managing director Charles Walker said.

“Ursula is a founding inventor of HER-Vaxx and her resume reflects her extraordinary prowess as a scientist, physician and educator and confirms her status as one of the leading lights in immuno-oncology globally.

“The CSO appointment is part of our ongoing initiative to put in place a first class management team capable of realizing the very significant opportunity that is our HER-Vaxx technology.”

Wiedermann added:

“Since my first introduction to Imugene several years ago I have strongly supported the HER-Vaxx development strategy and believe both our interests are aligned in bringing this exciting cancer technology to market as soon as possible.

“As the coinventor of the science and my new closer role in the company we can surely develop HER-Vaxx in a shorter time-frame.”

Recent Activity

In May, the company released research that demonstrated promising inhibition of tumour cells by its Her-Vaxx peptide vaccine for HER-2 positive gastric and breast cancer compared with Roche’s Herceptin drug in tumour model.

In empirical work, pre-clinical data showed that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

In empirical work, pre-clinical data showed that HER-Vaxx had improved growth inhibition on the human breast cancer cell line SKBR-3 compared with Herceptin, which also targets the HER-2/neu oncogene.

It also demonstrated identical inhibition at one third dose compared with Herceptin.

While clinical trials are required to confirm this, the result is promising given that Herceptin generated annualised sales of $6.9 billion.

“With improvements to the formulation of HER-Vaxx, and empirical-based optimism that HER-Vaxx appears superior to Herceptin, we are rapidly finalising plans to trial our novel HER-Vaxx immunotherapeutic vaccine in patients with gastric cancer later this year,” managing director Charles Walker said.

“We are developing HER-Vaxx to generate a fast and strong stimulation of patients’ immune systems to produce natural antibodies superior to Herceptin.”

The Phase 1b/2 clinical trial remains on track to begin in the second half of 2015.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx while Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understand of HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems

Adding interest, the trial will use a re-formulation of Her-Vaxx that shows more rapid and greater anti-cancer antibody production.

HER-Vaxx Pre-Clinical Research

The research was conducted by a team at the Medical University of Vienna under the direction of Professor Dr Ursula Wiedermann.

Her-Vaxx inhibited the proliferation of SK-BR-3 cells expressing high levels of HER-2/neu by 39% for 18.75ug dose, 58% for a 37.5ug dose and 66% for a 75ug dose.

This compared to a 39% inhibition by Trastuzamab at a 50ug dose.

The results indicate that Her-Vaxx is able inhibit the cancer cell growth with a dose of less than half that required for Herceptin while the higher dose is able to generate a response 70% greater.

Enhanced Formulation

In April, the company developed a new formulation of Her-Vaxx that demonstrated a ten-fold increase in the production of cancer fighting antibodies in pre-clinical animal model testing.

Manufacturing has also been simplified with increased reliability and lower cost.

Imugene has also been able to file a new patent that could extend coverage to 2036, which would allow the company another six years on the market at peak sales.

Upcoming Clinical Trial

The upcoming Phase 1b/2 trial is designed to yield as much data and information as possible to guide the company and potential partners to develop HER-Vaxx into a commercial pharmaceutical as quickly and as efficiently as possible.

Phase 1b is designed to confirm low toxicity and select the optimal dose from three different doses of HER-Vaxx. This part of the trial examines three groups of six patients, and will be “open label”, allowing data from the trial to be reported as it is conducted.

Phase 2 will use the dose identified in Phase 1b and assess clinical efficacy (prolonged patient survival) of HER-Vaxx in two groups of 34 patients in a placebo-controlled trial design.

This trial will improve understanding HER-Vaxx’s functioning from an early stage including showing the increased modulation of the immune system and demonstrating again the production of HER-2 antibodies by patients’ immune systems.

Such data may help potential partners in early assessments of the drug and its effect on the immune system, which is a key indicator of improvement in patient survival.

This study will be a key inflection point underpinned by many years of research.

Once the study begins, the company will increase business development work and meet with prospective partners to inform them of our progress, our innovative technology and trial design.

With the depreciation in the Australian dollar and incentives in Australia, Imugene plans to conduct the trial in as many Australian hospitals as possible without compromising speed or efficiency.

This will be better value for money, trial management will be more efficient and will likely benefit Australian trial participants with gastric cancer.

Analysis

The empirical data demonstrating that a higher dose of HER-Vaxx is able to inhibit cancer cell growth 70% greater than Herceptin is promising.

Shares in the company should trade higher on the news.

It also ensures the upcoming Phase 1b/2 clinical trial, which could provide a clinical demonstration of this efficacy, will be closely watched.

Success will allow Imugene to provide a superior alternative to Herceptin, which is a US$6 billion to US$7 billion per annum global market, providing significant upside.

HER-Vaxx also has lower production costs and potentially an opportunity for a single vaccination unlike Herceptin, which requires a more expansive treatment cycle.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX emerging companies with distribution in Australia, UK, North America and Hong Kong / China.

]]>Fri, 22 May 2015 09:00:00 +1000https://www.proactiveinvestors.com.au/companies/news/107296/imugene-research-shows-her-vaxx-tumour-inhibition-promise-107296.htmlhttps://www.proactiveinvestors.com.au/companies/news/156515/imugene-therapy-targets-cancer-at-melbourne-sydney-luncheons-60547.html
Imugene (ASX:IMU) is preparing to initiate this year the clinical program for its Her-Vaxx peptide vaccine, a B-cell based immunotherapy for HER-2 positive gastric & breast cancer.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors has secured MD Charles Walker to present to investors at the "Melbourne Investor Luncheon" on Tuesday 10th February and the "Sydney Investor Luncheon" on Wednesday 11th February.

REGISTER by clicking on the city below for additional details: Melbourne OR Sydney. Otherwise call (02) 9299 5001(02) 9299 5001 and ask for John.

HER-Vaxx is a proprietary peptide vaccine developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

It causes the immune system to generate cancer-fighting antibodies by stimulating a polyclonal antibody response to biomarker HER-2/neu.

HER-Vaxx has successfully completed a Phase I study in patients with breast cancer, confirming that it produced negligible toxicity and was tolerated by patients with no side effects.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>Fri, 06 Feb 2015 10:11:00 +1100https://www.proactiveinvestors.com.au/companies/news/156515/imugene-therapy-targets-cancer-at-melbourne-sydney-luncheons-60547.htmlhttps://www.proactiveinvestors.com.au/companies/news/156514/imugene-hits-milestones-on-the-road-to-her-vaxx-2015-clinical-program-59822.html
Australian immuno-oncology company Imugene (ASX:IMU) has met two more milestones as it prepares to initiate the clinical program for its Her-Vaxx peptide vaccine in 2015.

The company has substantially finalised the clinical protocol for the Phase Ib/II clinical trial in patients with gastric cancer.

It has also appointed respected US nonclinical contract research organisation (CRO) WIL Research to conduct important FDA IND enabling preclinical studies to support the clinical trial planned by the company.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

It was developed by one of Europe’s leading cancer institutes with about $10 million already invested in the technology.

The next stage of development will be a Phase Ib/II study in patients with gastric cancer to confirm safety, evaluate optimal dosing, and to show efficacy.

This is expected to start in the second half of 2015 following the appointment of a CRO to manage the trial.

Phase Ib will be an open label Trial, in which both the researchers and participants know which treatment is being administered. This will include 18 patients divided into 3 groups of 6.

The endpoints of the trial will establish the HER-Vaxx dosage level for Phase II of the study, evaluate toxicity, measure immunogenicity (immune response), and test a booster schedule that compares 4 weeks of treatment to 8 weeks.

The Phase II Trial will expand to around 68 patients drawn from both Australia and Europe, and be a blinded, placebo controlled trial that evaluates efficacy, safety, and immune response. This means that 34 patients will be treated with HER-Vaxx and chemotherapy, and 34 patients treated only with chemotherapy.

The endpoints of the trial will establish an overall survival rate, and progression to survival. The secondary endpoint will measure immune response.

This robust Phase II trial is focused on attracting a Big Pharma partner to continue development work and commercialisation of HER-Vaxx.

Gastric cancer global overview

Gastric cancer is the second leading cause of cancer mortality, and the fourth most common cancer in the world. Approximately 934,000 new cases of gastric cancer are diagnosed each year which produces approximately 700,000 deaths that account for 10.4% of cancer deaths worldwide, each year.

The European Union (27 states) estimated around 83,000 new cases of stomach cancer were diagnosed, and recorded 55,896 deaths in the latest reporting year.

In 2012 the U.S. estimated 21,300 new cases, and 10,540 deaths from stomach cancer.

Australian authorities estimate that there are about 1,900 new cases each year, and China has the largest patient population that makes up 42% of worldwide cases.

The median overall survival rate for advanced gastric cancer is estimated to be less than 12 months.

Imugene has achieved two milestones as it continues preparations to initiate the clinical program for its Her-Vaxx peptide vaccine in the second half of 2015

The finalisation of the clinical protocol for the Phase Ib/II clinical trial and appointment of WIL Research to conduct important FDA IND enabling preclinical studies are both key steps towards conducting an efficient high quality Phase II trial that will draw attention from pharmaceutical companies.

With significant news flow and price catalysts milestones in the development of HER-Vaxx, one of the world’s most advanced B-cell vaccines in sight, there is potential for the current valuation to lift in 2014/15.

Her-Vaxx has potential to improve upon Roche’s blockbuster Herceptin drug that generated annualised sales of $6.9 billion and targets the same biomarker.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

The ASX has granted the company a trading halt, with its shares placed in pre-open.

Imugene is developing B-cell based immunotherapies, known as HER-Vaxx, for HER-2 positive gastric and breast cancer.

The halt will remain in place until the opening of trade on Wednesday 5th November 2014, or earlier if an announcement is made to the market.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

The patent will protect specific cancer vaccine formulations in Israel until 2027.

HER-Vaxx stimulates a polyclonal antibody response to the HER-2/neu receptor, the same biomarker targeted by the $US6.9 billion per annum drug Herceptin®.

HER-2/neu is known to be over-expressed on various tumours including gastric, breast, ovarian and pancreatic cancers.

HERVaxx has completed a Phase 1 study in breast cancer; the next stage of development will be a Phase 2 study in gastric cancer, which is the second most common cause of cancer-related death in the world

Imugene secured full rights to manufacture the cancer immunotherapy as part of its acquisition of BioLife Science in December last year.

The first patent was assigned from Pevion Biotech of Switzerland, protecting Her-Vaxx in several major markets until 2030.

Imugene also holds an exclusive global license covering a patent for the virosome vaccine delivery platform, which is used in the vaccine's manufacture.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>Mon, 24 Mar 2014 11:46:00 +1100https://www.proactiveinvestors.com.au/companies/news/156512/imugene-to-be-granted-patent-for-cancer-vaccine-in-israel-53848.htmlhttps://www.proactiveinvestors.com.au/companies/news/156511/imugene-secures-intellectual-property-over-a-proposed-cancer-vaccine-51301.html
Imugene (ASX: IMU) has secured full rights to manufacture the cancer immunotherapy Her-Vaxx as part of its acquisition of BioLife Science QLD, which is due to close on December 20th.

The first patent has been assigned to Biolife from Pevion Biotech of Switzerland, protecting Her-Vaxx in major markets until 2030.

Biolife has additionally been granted an exclusive global license from Pevion in the field of oncology covering a patent for the virosome vaccine delivery platform, which is used in the vaccine's manufacture.

Biloife acquired the rights to the novel cancer immunotherapy treatment platform, developed by reseach scientists at the University Medical School in Austria.

The immunotherapy induces an antibody response against breast and gastric cancers.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>Thu, 19 Dec 2013 15:30:00 +1100https://www.proactiveinvestors.com.au/companies/news/156511/imugene-secures-intellectual-property-over-a-proposed-cancer-vaccine-51301.htmlhttps://www.proactiveinvestors.com.au/companies/news/156510/imugene-limited-to-disclose-acquisition-capital-raising-49296.html
Imugene Limited (ASX: IMU) is preparing to divulge details of an acquisition, along with a capital raising.

The ASX this morning has granted the company a trading halt, with its shares placed in pre-open.

Imugene is currently focused on drug delivery technology, and is looking to commercialising these based on its novel buccal (drugs administered via the cheek) Linguet™ technology.

The halt will last until the opening of trade on Wednesday 23rd October 2013, or earlier if an announcement is made to the market.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>Mon, 21 Oct 2013 12:00:00 +1100https://www.proactiveinvestors.com.au/companies/news/156510/imugene-limited-to-disclose-acquisition-capital-raising-49296.htmlhttps://www.proactiveinvestors.com.au/companies/news/156509/imugene-to-be-granted-european-patent-for-bone-loss-prevention-drug-delivery-technology-48553.html
Imugene (ASX: IMU) is expected to trade higher following the company being allowed a European patent for its Linguet™ drug delivery technology.

It is significant as it protects around Linguet’s™ formulations and other specific excipients for a class of drugs that prevent the loss of bone mass.

The European Patent Office has issued an Intention to Grant Communication for Linguet™.

Linguet is now protected by the same patent in three key markets including Europe, Japan and China.

The patent is another step for Imugene on the path to commercialisation adding value to its core technology.

The next key milestone to be achieved for the company is the U.S. patent application, which would effectively provide Imugene with global coverage.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>Fri, 27 Sep 2013 15:00:00 +1000https://www.proactiveinvestors.com.au/companies/news/156509/imugene-to-be-granted-european-patent-for-bone-loss-prevention-drug-delivery-technology-48553.htmlhttps://www.proactiveinvestors.com.au/companies/news/156508/imugene-looks-to-melt-a-vitamin-d-in-your-mouth-46505.html
Imugene (ASX:IMU) is looking at developing a melt in the mouth vitamin D tablet after consumer research indicated there could be robust demand for such a product.

It has entered discussions to commercialise the meltlet with Australian vitamin suppliers.

Global demand for vitamins will hit the $30 billion mark by 2015 according to the company.

Imugene may be onto something as some consumers have difficulty swallowing tablets and don't like the taste of certain vitamins.

It may also find this would alleviate anxiety from younger consumers at the prospect of swallowing tablets.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

]]>Thu, 08 Aug 2013 10:20:00 +1000https://www.proactiveinvestors.com.au/companies/news/156508/imugene-looks-to-melt-a-vitamin-d-in-your-mouth-46505.htmlhttps://www.proactiveinvestors.com.au/companies/news/156507/imugene-granted-chinese-patent-for-drug-delivery-system-launches-share-purchase-plan-42620.html
Imugene (ASX: IMU) has secured a key Chinese patent covering its novel drug delivery technology Linguet™ for use in the prevention of loss of bone mass, which occurs in diseases such as osteoporosis.

The technology is now protected in two key markets, with the same patent formulation allowed in Japan last month, allowing Imugene to explore two lucrative Asian markets ahead of the anticipated regulatory approval of Linguet™ Vitamin D next year.

Linguet™ enables the active ingredient of drugs to be absorbed straight into the bloodstream when placed inside the cheek (via the buccal mucosa) or under the tongue (sublingual).

The Chinese patent covers Linguet’s™ formulations and other specific excipients for a class of drugs that prevent the loss of bone mass, known as bisphosphonic acids and bisphosphonates, which are used to treat conditions such as osteoporosis and multiple myeloma.

Osteoporosis affects almost 70 million Chinese over the age of 50, including 22.5% of men and 50.1% of women.

The condition causes some 687,000 hip fractures in China, a result of the bones becoming more porous and fragile.

Vitamin D feasibility testing

Vitamin D deficiency is associated with a wide range of conditions including osteoporosis, certain forms of cancer, pre-diabetes, and cardiovascular health.

Vitamin D deficiency is a therapeutic area that has seen rapid growth in sales over the past five years, and has become one of the fastest growing nutrients worldwide.

Vitamin D sales in the U.S. have grown from $141.1 million in 2005 to $366.3 million in 2009, with CARG growth expected to be 11.2% in the U.S. between 2009 and 2014.

Imugene’s novel rapid Linguet™ form of Vitamin D has now completed feasibility testing and formulation development.

The company expects to file for regulatory approval in the UK and licence the product to a third party in 2014.

Share purchase plan

Imugene has also launched a share purchase plan offering shareholders the opportunity to subscribe for between $1,000 and $15,000 worth of new fully paid ordinary shares.

Under the share purchase plan, the offer price of each new share will be at a 10% discount to the volume weighted average price of Imugene shares traded on the ASX over the 10 consecutive trading days prior to the date new shares are to be issued – expected to be Tuesday, 4 June 2013.

The amount of capital raised will be dependent on participation in the share purchase plan, but the number of new shares issued will not exceed 30% of shares already on issue.

The funds raised will be used to advance Imugene’s lead products to regulatory filing in the UK and European Union.

Imugene has selected three priority targets – Vitamin D, pain and Parkinson’s Disease – where it can deliver improved versions of existing drugs that meet a significant unmet need.

The funds will also be used to advance development of reformulation of the over-the-counter pain drug, Ibuprofen – marketed as Nurofen® and Advil® in Australia and the UK by Reckitt Benckiser and Pfizer respectively.

While these drugs have a share of a global market of $US5.37 billion per annum, the treatments come with serious side effects such as gastric irritation and stomach ulcers, particularly when used at higher doses for extended periods of time.

Positive results from a Phase I clinical trial on a Linguet™ Ibuprofen (LC201) demonstrated that the Linguet™ drug delivery platform technology improved patient compliance and speed of action.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China. ]]>Tue, 30 Apr 2013 09:30:00 +1000https://www.proactiveinvestors.com.au/companies/news/156507/imugene-granted-chinese-patent-for-drug-delivery-system-launches-share-purchase-plan-42620.htmlhttps://www.proactiveinvestors.com.au/companies/news/156506/imugene-focuses-on-developing-pharmaceutical-products-for-early-revenues-33646.html
Imugene (ASX: IMU) has outlined its strategic new direction as a developer of pharmaceutical products following the recent acquisition of the Linguet™ drug delivery technology.

The company’s focus is on pushing early revenue generating products, rather than a traditional biotech platform technology that focuses on a single opportunity licensing deal far into the future.

Imugene is targeting early 2014 sale of product in Europe, specifically for the treatment of Vitamin D deficiency – a therapeutic area that has seen rapid growth in sales over the past five years, and has become one of the fastest growing nutrients worldwide.

Vitamin D sales in the U.S. have grown from $141.1 million in 2005 to $366.3 million in 2009, with CARG growth expected to be 11.2% in the U.S. between 2009 and 2014.

Vitamin D deficiency has been linked to a wide range of conditions including pre-diabetes (metabolic syndrome), osteoporosis, cardiovascular health, and Alzheimer’s.

A significant association of Vitamin D deficiency with the rate of progress of low-risk prostate cancer is also currently being investigated.

Imugene’s strategy is to target pharmaceutical products that do not need significant clinical investment to gain regulatory approval, ensuring the most cost effective and most rapid path to market.

The Imugene Linguet product uses a specific form of Vitamin D which has been shown to be five times more effective in raising blood serum levels of Vitamin D than the usual colecalciferol form of the vitamin that has been traditionally used as a supplement.

Linguet™ technology

Linguet™ is a tablet placed under the tongue or the buccal cavity in the mouth (cheek) and allowed to dissolve releasing the active drug, which is absorbed immediately into the blood stream via the mucosa of the mouth.

The drug thereby bypasses the gastrointestinal tract and is able to reach its target more rapidly and in the process significantly lower side effects.

A key benefit of the Linguet technology is that it’s an oral delivery form with kinetics almost as fast as an injection.

Potential product pipeline

In addition to Vitamin D, over the next 12 months, a further four specific pharmaceutical product programs are scheduled for development.

Generic pharmaceutical products focusing on Parkinson’s Disease and status epilepticus are planned for release later in 2014, also in Europe initially.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums. ]]>Thu, 20 Sep 2012 13:50:00 +1000https://www.proactiveinvestors.com.au/companies/news/156506/imugene-focuses-on-developing-pharmaceutical-products-for-early-revenues-33646.htmlhttps://www.proactiveinvestors.com.au/companies/news/156505/imugene-readies-to-update-market-on-potential-acquisition-in-asx-trading-halt--28319.html
Imugene (ASX: IMU) has been granted a trading halt by the ASX pending an announcement concerning a potential acquisition, with the company placed in pre-open.

While no further details were released, Imugene said in its recent quarterly report it continued to review new business opportunities to add value to its existing assets.

Imugene is pursuing one particular opportunity and is currently negotiating terms.

Earlier this year the company took a step back from the development of its poultry vaccines following a review of its activities.

As a result of the review, Imugene plans to focus on the components of its technology that have strong commercial prospects, in particular its pig vaccines.

The halt will last until the earlier of an announcement being made available to the market, or the opening of trade on Thursday 3 May.

Proactive Investors is a market leader in the investment news space, providing ASX “Small and Mid-cap” company news, research reports, StockTube videos and One2One Investor Forums. ]]>Tue, 01 May 2012 14:40:00 +1000https://www.proactiveinvestors.com.au/companies/news/156505/imugene-readies-to-update-market-on-potential-acquisition-in-asx-trading-halt--28319.htmlhttps://www.proactiveinvestors.com.au/companies/news/156504/imugene-steps-back-from-poultry-vaccines-24036.html
Imugene (ASX: IMU) has decided to place the development of poultry vaccines on hold following a review of its activities.

The company undertook a review of its portfolio of vaccine products and intellectual property after the termination of a global licence agreement with Novartis in September 2011.

As a result of the review, Imugene plans to put its focus on components of its technology that have strong commercial prospects; in particular the company’s pig vaccines.

In addition, it is considering new approaches for delivering certain vaccines in order to maximise their efficacy.

Initially, Imugene will focus on new delivery approaches for the Porcine Reproductive and Respiratory Syndrome vaccine.

The company is involved in discussions with interested parties to gauge the level of commercial interest in progressing its technology.

In addition to putting its poultry vaccines on the back burner, Imugene plans to take a prudent approach to expenditure in 2012. ]]>Wed, 11 Jan 2012 15:55:00 +1100https://www.proactiveinvestors.com.au/companies/news/156504/imugene-steps-back-from-poultry-vaccines-24036.htmlhttps://www.proactiveinvestors.com.au/companies/news/156503/imugene-exits-trading-halt-with-global-license-agreement-announcement-19227.html
Imugene (ASX: IMU) has been released from a trading halt post the announcement that the company has received notification of termination of the global license agreement with Novartis.

The agreement was for the development and commercialisation of its vaccines for pigs and poultry.

Imugene said that the response to further enquiries regarding the decision, was that the reason for termination was “an internal decision by the licensor to discontinue investment in the development of this technology”.

The company added that no further information has been provided regarding the termination, and during the recent management visit to the U.S. operations there was no indication that termination of the venture was being considered.

Imugene added that the notice of termination is very unexpected, and that the company is disappointed with the outcome.

]]>Fri, 02 Sep 2011 14:48:00 +1000https://www.proactiveinvestors.com.au/companies/news/156503/imugene-exits-trading-halt-with-global-license-agreement-announcement-19227.htmlhttps://www.proactiveinvestors.com.au/companies/news/156502/imugene-in-pre-open-pending-strategic-alliance-announcement-19159.html
Imugene (ASX: IMU) has been granted a trading halt by the ASX pending the release of a strategic alliance announcement, with the company's shares placed in pre-open.

The company has not yet announced any further details on the alliance, with the trading halt to remain in place until the earlier of the announcement - or the commencement of trading on Monday 5 September.

During financial year 2011 Imugene executed an agreement with an international animal health company, to commercialise Imugene's vaccines for pigs and poultry.

The Imugene business model focuses on maximising income from the receipt of research fees, license and royalties.

Imugene has produced vaccines for the H1N1 and H3N2 strains. The vaccines have completed the laboratory construction phase and are ready to progress to animal trials for efficacy testing.

Commercial parameters of the Swine Influenza vaccines are now being evaluated.

The vaccines will enter the product development program if commercial parameters are satisfied.

Imugene’s Swine Influenza vaccine development program commenced in early 2008 and has identified both H1N1 and H3N2 vaccines as potential vaccines for development. Swine Influenza is a respiratory viral disease of pigs and outbreaks occur throughout many parts of the world. Vaccination against Swine Influenza is routine in many countries.

Imugene earned a net profit of $1.9 million on revenues of $3.1 million for the half year to 31 December 2008.

A strategic alliance was struck with Merial Limited agreed in December 2008. This leverages the strength of Merial’s experience and infrastructure to the development of Imugene’s innovative range of vaccine candidates. In return for exclusivity over the Imugene technology, Imugene will receive annual payments, milestone fees and royalties.